Mitsar-BFB Operation Manual 21.11.2007 - Bio
Contents
1. 28 Mitsar BFB Operation Manual iv Mitsar Product Warranty Mitsar warrants that each product we sell you is free from defects in labor and materials and shall conform to its product specifications as defined in the user documentation If the product does not function as warranted during the warranty period we will repair or replace it without charge If in our judgment we are unable to do so you may return it to us and we will refund your money Limit of Warranty Misuse accident modification unsuitable physical or operating environment improper maintenance or damage caused by a product for which we are not responsible may void the warranty Certain components may have separate warranty periods as stated in the product user documentation Consumables are not covered under warranty Items Not Covered by Warranty We do not warrant uninterrupted or error free operation of a product We provide certain non Mitsar products on an as is basis Non Mitsar manufacturers or suppliers may provide their own warranties to you Separate software warranty is provided with software user documentation Customer Responsibility This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this manual accompanying labels and inserts A defective product should not be used Parts which may be broken or missing or those that are2. RAN RR SNR R DAR R S ARR 4 2 6 SWITCHING Eo ERES EVER RECS RE ERES KVER REESE AERE AES KERRECERRE ERES EVER REEERREEREEEREERRIESER 4 2 7 SWITCHING OFF hak culina enbioga E eil ona Cu 5 2 8 LEAKAGE CUR ENT 5 2 9 TRANSPORTATION revo rn Fog aree Few Lora Fog rero Fo ew La Ug rego Fea ca TURN ETE 5 2 10 OPERATION 5 2 11 UTILIZATION 5 dics excssicc eres acct cxcadiacaxessicaxcaacesacesaicaicasvecatessccbaicaaieeadensiedaieasizeetetaicted 5 3 BIOFEEDBACK TRAINER TECHNICAL 212 6 3 1 MITSAR BFB AMPLIFIER BOX ceccceecceecceesceeeeeeseneseueeeueeeueseuseeueeeusseuseeuseeussensseuseeuseenseoees 6 3 1 1 Amplifier Box basic technical data 7 3 1 2 Amplifier Box simplified functional 8 3 1 3 Amplifier Box principle of operation 9 3 1 4 Safety measures ER RR 9 3 2 MITSAR BFB JAMMER woes edecccdeecdoeciedcceedeewteecdevucaeedeeudoeedevucavensvwcuscuevucaveussuassedsveussuusvwareens 11 3 2 1 Jammer basic technical 11 3 2 2 Jammer simplified functional
3. VideolN VideoOUT AudiolN AudioOUT Figure 7 Jammer simplified functional diagram e MUX Multiplexer e SS Sync Selector e MIX Mixer e DVR Digital Volume Regulator e OA Output Amplifier e uC Microcontroller e Interface Converter e PS Power Supply e Personal Computer Mitsar BFB Operation Manual 12 3 2 3 Jammer principle of operation Video and audio signals enter the Multiplexer input which provides their through passing to the output if the power supply voltage is off On Jammer duty video signal after the Multiplexer enters the Sync Selector which produces microcontroller driving signals at the instants of field sync pulse and line sync pulse appearing Microcontroller generates disturbing signal similar to the input video signal Video signal and disturbing signal relations depend on PC data came by serial interface Initial video signal and disturbing signal intermingle in the Mixer headed by the microcontroller and enter the Jammer output Audio signal after the Multiplexer enters the Digital Volume Regulator which lessens it depending on PC data came by serial interface The regulator is headed by the microcontroller After the Digital Volume Regulator audio signal enters the Output Amplifier and hereafter the Output Connector Data are accepted from PC using the standard USB type interface through the interface convert
4. Commissioned date signature and the seller s seal Assigned for warranty service by Head of the enterprise signature and stamp The customer s signature Mitsar BFB Operation Manual 30
5. Recommended for advanced users lt Back Cancel Select type of Setup you prefer Press Next button to continue installation Select the components you want to install clear the components you do not want to install Components Piuyian Execulables w Shared DLLs w DataBase s Sounds Description Shange Space Required 405999 Space Available 2096832 lt Back Next gt Select components you want to install Don t install Sounds component if you don t plan to use auditory biofeedback Press Next button to continue installation Mitsar BFB Operation Manual 25 Select Program Folder x Setup will add program icons to the Program Folder listed below You may type a new folder name or select one from the existing Folders list Click Next to continue Program Folders BrainT une Existing Folders Ac Broderbund Software Brother HL 1230 Harry Potter II Microsoft Developer Network Microsoft Visual Studio 6 0 lt Cancel Type new folder name if you want Press Next button to continue installation Setup Complete Setup has finished installing BrainT uner on your computer Setup can launch the Read Me file and BrainTuner Choose the options you want below Click Finish to complete Setup Press Finish button to complete Setup After finishing of Setup you need to run BrainTune program
6. 12 3 2 3 Jammer principle of 13 Side STARTING UP ee 13 3 4 OPERATION PROCEDURES rie eser Fr nnn wa anna x a Nana Ra ena nena YR nM RR Ea Mi ER ERR 14 3 5 MAINTENANCE ou ceccceecceecceeeceeeeeeeeueeeaeeeaseeaseeuseeaeeeaeenaeenaeenaeenaueneeenseeeaeeseenseenseeneseneeeneeens 16 9 6 INDICATORS akc CEPR CER 17 4 BIOFEEDBACK TRAINER CONNECTION 65 18 4 1 BE B TRAINING WITH COMPUTER Chin Erde RISE 18 4 2 BFB TRAINING WITH COMPUTER AND nnne nnne nennen nnn nnn 19 5 BIOFEEDBACK TRAINER DRIVERS INSTALLATION _ 20 Mitsar BFB Operation Manual iii 5 1 AMPLIFIER BOX DRIVER INSTALLATION eene nnne nnnm nnne nnne rans anna hn sane sana ansa nada 20 5 2 JAMMER 23 6 BRAIN TUNER SOFTWARE INSTALLATION 1 24 T 55 ar nnd Six ei 27 8 DATA ON INSTALLATION AND ASSIGNMENT TO
7. Ed 3 0 Add 1 2 1993 98 The standard IEC 60601 1 1988 defines the permissible leakage current The connection several systems to the patient the leakage current will sum that can result to not permissible value of total leakage current and running the risk of patient injury Check the total values of leakage current of several systems before connection them to the patient 2 9 Transportation Turn off the system before transportation 2 10 Operation life The operation life is limited by five years after installation The keeping period should not be longer that one year after production and before installation 2 11 Utilization The utilization of the system and the batteries should be done in correspondence to the domestic regulation Mitsar BFB Operation Manual 2 3 Biofeedback Trainer technical data 3 1 Mitsar BFB Amplifier Box The Mitsar BFB Amplifier Box complies in accordance with the requirements of technical specifications TU 9441 005 521 18320 2005 The Amplifier Box connector layout is presented on Figures 1 and 2 1 Neutral electrode connector 2 Channel 1 electrode connectors yellow plus green minus Channel 1 3 Channel 2 electrode connectors yellow plus green minus Channel 2 4 USB connector 5 Channel 1 bad quality indicator yellow LED 6 Channel 2 bad quality indicator yellow LED 7 Power and low battery indicator green LED M ITSA
8. driver installation and use of the software are given in Chapter 6 of this manual 12 Methods of installation and use of the software are given in Chapter 6 of this manual After installation of the software carry out trial operation of the system in accordance to the instructions presented in Chapter 6 of this manual 3 4 Operation procedures 1 Operating the software Usage of the software is described in the user s manual included in the set of delivery of the system 2 Neutral ground input connectors For successful BFB training you must use neutral electrode Connector for this electrode is marked N If the neutral electrode is disconnected or defective instead of EEG you can observe as usual a distorted low frequency signal 50 60 Hz interference or saturated amplifiers with pencil beam pattern 3 BFB training features The main reason of unsatisfactory operation of the Biofeedback Trainer may lie in sporadic line 50 60 Hz interferences or high frequency interferences In some cases when the electrodes were not installed appropriately the Amplifier Box generates noise like sound using built in speaker and indicates using yellow LEDs channels with inappropriate quality Mitsar BFB Operation Manual 14 of the electrodes installation These interferences may be caused by various reasons e The electrodes are contaminated Follow electrode maintenance instructions enclosed to electrodes e Unsati
9. ecu A conu e UN SINN ODD RUN V ITEMS NOT COVERED BY WARRANTY V CUSTOMER 6 V MITSAR WARRANTY AND POST GUARANTEE 5 VI SAFETY SUMMARY E ete ee c E eec ca VII DESEE AS E RES EERE AIS ETES AS EEEE SES TATEA ATEA VII leggo le IX EQUIPMENT LEABEL INQ Ee eee Eutr ena a a eR Eo cx ane os enu Eus ena otv an NUR XI 1 BIOFEEDBACK TRAINER 1 1 1 AVAILABLE ADDITIONAL 15 kan RAN RR ERR RR SAN nnna 1 1 2 DELIVERY SET riii eei cet opel veda Desde dag Ee cesi Yea died lel 2 2 BIOFEEDBACK TRAINER ADDITIONAL INFORMATION 3 21 GOMPUTER E cvsbei EE A 3 2 2 SOFTWARE 2 3 EEECTRODES rire iretur ui err tar Ul wr rc tar wa er rw c ru wa ew a 3 2 4 ANTIVIRUS SOFTWARE nessuna nnn hana ak SNR RR DAR RR SNR R ARR RDANRR 3 2 5 SYSTEM INSTALLATION
10. electrodes positioning caps should be certified in compliance with domestic standards Medical Device Directive MDD 93 42 EEC or FDA requirements Mitsar BFB Operation Manual viii WARNING The personal computers are important parts of Biofeedback Trainer but they are delivered separately All computers used with Biofeedback Trainer should be certified in compliance with domestic standards for example IEC 60950 for Europe WARNING Clean Biofeedback Trainer components with a soft cloth lightly moistened with mild detergent solution or 70 alcohol solution The components should be disconnected from power supply during cleaning WARNING Disinfect Biofeedback Trainer components with 10 whiten solution based on chlorine gt gt gt WARNING Follow the recommendation of companies producing electrodes and electrodes caps concerning cleaning and disinfection of them CAUTIONS CAUTION Proper use of this system depends careful reading of all instructions and labels CAUTION Turn OFF system power before connecting or disconnecting any system component s or accessories You may damage device s Mitsar BFB Operation Manual ix CAUTION Do not disconnect or reconnect any system components or accessories with the system powered on You may damage the components CAUTION A power interruption that occurs during a recording sessi
11. personal of medical institute or clinic medical doctors and medical nurses and other medical staff The personal intended to work with the Biofeedback Trainer should be experienced enough in technique of clinical neurofeedback observation The user should be familiar with operation system Windows XP also 1 1 Available additional manuals There are additional manuals in which the detailed information about software of system is included 1 User manual for BrainTuner program Mitsar BFB Operation Manual 1 2 Delivery set The delivery set can include the next components in dependence on customer order Mitsar BFB biofeedback trainer consisting MIRN 943119 005 of 1 1 Mitsar BFB Amplifier Box MIRN 943119 005 01 1 1 1 1 5 USB connection cable 2 1 2 Mitsar BFB Jammer MIRN 943119 031 m 1 Accessories 2 Audio video cable Philips SWV3533 1 is delivered separately on the client s call Mitsar BFB Operation Manual 2 2 Biofeedback Trainer Additional information 2 1 Computer The personal computer is important part of Biofeedback Trainer but it is delivered separately All computers and other peripheral devices as monitors printers and etc used with Biofeedback Trainer should be certified in compliance with domestic standards for example IEC 60950 for Europe 2 2 Software components Most important component of system is the software It controls the hardware components acquires
12. 0601 1 1 1992 14 Electromagnetic compatibility of the Biofeedback Trainer complies with requirements of standard IEC 60601 1 2 1993 15 Working condition temperature range 10 to 435 C moisture range 25 to 95 without condensation 3 1 2 Amplifier Box simplified functional diagram Figure 3 Amplifier Box simplified functional diagram e EL Electrodes e GA Gain Amplifier Quality Monitoring Circuit e ADC Analog to Digital Converter e ISO Electrical Isolation Circuit e uC Microcontroller e PS Power Supply e IC Interface Converter IB Isolation Barrier e PC Personal Computer Mitsar BFB Operation Manual 8 3 1 3 Amplifier Box principle of operation Electrodes avert the signal from the brain and direct it to the Gain Amplifier The signal in the Gain Amplifier increases up to the level concerted with the ADC measurement range and undergoes the analogue filtration Increased signal is moved to the ADC input which modifies the signal into the 12 digit code Quality Monitoring Circuit controls the gain amplifiers mode It defines DC input and output levels and power line noise which indirectly characterize degree of quality of electrodes installation or their absence and passes it to the controller ADC synchronization data communication with the computer and quality of electrodes installation evaluation is provided by microprogram downlo
13. Maintenance 1 It is recommended to take the batteries out the compartment if service interruption exceeds one month presumably 2 Exhausted batteries should be replaced by new ones when required The signs of batteries exhaust are e Special warning message about necessity of battery change e and more frequent warning No response from ADC or No reply from the device or Channel faulty 3 The device should be cleaned by standard means CAUTION Do not autoclave any parts of Biofeedback Trainer CAUTION Do not use acetone for cleaning the components of system Mitsar BFB Operation Manual 16 4 The electrodes should be cleaned and sterilized by as described into their accompanying documentation 3 6 Indicators On the Amplifier Box faceplate three LED indicators are situated two of the yellow color and one of the green Green LED Fig 1 pos 7 flashes on when the Amplifier Box is being switched on Even glow corresponds normal functioning When cells de energize and it is necessary to change them the indicator starts blinking approximately a cycle per 4 seconds It is attended with discontinuous sonic signal Yellow LEDs Fig 1 pos 5 6 flash on if the electrodes in the channel next to the appropriate indicator are not installed correctly for the normal functioning Quality control is carried out only for the channels which were chosen for the current training in Brain
14. Mitsar Co Ltd Biofeedback Trainer MITSAR BFB OPERATION MANUAL MIRN 943119 005 RE 1 Channel 2 MITSAR O Biofeedback Trainer POWER Saint Petersburg 2007 Attention The information in this document is subject to change without notice Mitsar Co Ltd makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose Mitsar assumes no responsibility for any errors that may appear in this document Mitsar makes no commitment to update or to keep current the information contained in this document No part of this document may be copied or reproduced in any form or by any means without prior written consent of Mitsar Co Ltd Mitsar Co Ltd is an ISO 9001 certified corporation In case of any troubles problems or requests please do not hesitate to contact us in writing Mitsar Co Ltd Polytekhnicheskaya str 6D Saint Petersburg 194021 RUSSIA via E mail info mitsar spb ru by phone or FAX 7 812 331 09 32 297 90 13 For more information please visit http www mitsar medical com Mitsar BFB Operation Manual ii Contents MITSAR PRODUCT WARRANTY V MITSAR PRODUCT RR V LIMIT OF WARRANTY cin necin
15. NG The personal computer as a part of Biofeedback Trainer must not be situated closer than 1 5 m from a patient gt D WARNING PC monitor printer TV set and video player as a part of Biofeedback Trainer must be connected to power supply line only via socket equipped with ground contact Mitsar BFB Operation Manual vii WARNING Do not contact simultaneously to patient and any non medical part of Biofeedback Trainer such as PC monitor printer TV set and video player WARNING Do not turn on any system power until all cables have been properly connected and verified WARNING To reduce the risk of patient injury turn on any system power before beginning of connection any patient electrodes WARNING To reduce the risk of patient injury disconnect all electrodes from the system before you turn off system power WARNING Connect patient electrodes to fully electrically isolated physiological devices only Connection to any other devices or external electrical outlets may result in personal injury WARNING Any devices connected to Biofeedback Trainer should be certified by Mitsar Co Ltd to provide the conformity of system to requirements for leakage current in accordance with the standard IEC 60601 1 1 1992 for medical electrical systems gt gt gt D WARNING Any devices connected to Biofeedback Trainer including electrodes and
16. R Biofeedback Trainer Figure 1 Mitsar BFB Amplifier Box connectors and indicators layout front view Mitsar BFB Operation Manual 6 8 Label 9 Battery compartment cover Figure 2 Mitsar BFB Amplifier Box rear view 3 1 1 Amplifier Box basic technical data 1 Weight of the Amplifier Box not more than 1 kg Weight of the package without a computer and a printer not more than 10 kg 2 Dimensions of the Amplifier Box 160 x 95 x 35 mm 3 The Amplifier Box operates by computer system 4 Amplifier Box is provided from internal power supply four dry cells or storage batteries type AA R6 supply voltage 3 0 to 6 5 V 5 The Amplifier Box consumption current not more than 0 07 A 6 The Amplifier Box total operation time with one set of alkaline batteries not less than 50 hours 7 PC interface USB 8 Digital sampling rate per channel 250 Hz 9 Number of channels 2 10 Input voltage range 10 to 200 uV 11 Irregularity of the frequency amplitude response not more than 10 within the Mitsar BFB Operation Manual 7 designated frequency range 4 20 Hz 12 Electrical safety of the Amplifier Box complies with the requirements for instruments with internal power supply BF standards IEC 60601 1 1988 13 The Biofeedback Trainer complete with line powered PC complies with the electrical safety requirements class 1 type BF standards IEC 60601 1 1988 and 6
17. Tuner see documentation of this program E g if we use for the training the first channel only bad quality of electrodes installation in the second channel would not be controlled and indicated The glow of the electrodes installation quality is attended by continuous noise like sonic signal and additional indication in the Brain Tuner program see documentation of this program NOTE Neutral electrode relates to both channels If it is installed inappropriately the indicators of all channels chosen for training would flash on On the Jammer faceplate the green LED is situated Fig 2 pos 3 Its glow marks that the Jammer is ready for work Mitsar BFB Operation Manual 17 4 Biofeedback Trainer connection diagrams There are the connection diagrams for the typical Biofeedback Trainer configuration 4 1 BFB training with computer USB cable Amplifier Box Figure 8 The connection diagram for BFB training with computer WARNING The personal computer must not be situated closer than 1 5 m from a patient Mitsar BFB Operation Manual 18 4 2 BFB training with computer and Jammer MEET uni Video Out LEN Villon Videoplayer USB cable USB cable Audio Video cable Jammer Amplifier Box Figure 9 The connection diagram for BFB training with computer and Jammer WARNING The personal computer Jammer TV set and video player must not be si
18. aded in microcontroller Data are transferred to PC using standard USB type interface through the electric isolation circuit and interface converter which provides coordination of microcontroller and USB serial data link ISO plays the part of isolation barrier and holds the voltage of 4 kV minimum Amplifier Box delivery is implemented by galvanic cells internal power supply Power Supply produces voltage necessary for the work of device Microprogram being executed in Amplifier Box microcontroller completes Amplifier Box switching on and off and reads the digital signal data Also the microprogram reveals by using LEDs and notifies by sonic signals that electrodes were not installed correctly ore cells have low voltage level 3 1 4 Safety measures 1 Regarding operation safety the Amplifier Box complies with the requirements of standard IEC 60601 1 92 as a device with internal BF type power source The Biofeedback Trainer conjointly with a line supplied PC complies with the electrical safety requirements class I type BF standards IEC 60601 1 1988 IEC 60601 1 1 1992 2 General safety of the Biofeedback Trainer is provided by fulfillment of the requirements of standard IEC 60601 1 1 1992 3 The Amplifier Box operates in a patient s environment 4 The personal computer represents a subsystem of non medical equipment and must be situated at distance from a patient providing impossibility of intended or accidental contact between a
19. and set correctly the I O ports using Setup Equipment parameters command If you plan to use auditory biofeedback you need to set parameters of volume control using Setup Biofeedback parameters command Mitsar BFB Operation Manual 26 7 Deed of commission Biofeedback trainer Mitsar BFB including The Amplifier Box Mitsar BFB serial found to be ready for operation The Jammer Mitsar BFB serial found to be ready for operation Manufactured on Mitsar Co Ltd date signature seal Mitsar BFB Operation Manual 27 8 Data on installation and assignment to operation Biofeedback Trainer Mitsar BFB serial have been installed and commissioned Date of installaton Signature Position Name Mitsar BFB Operation Manual 28 MITSAR CO LTD WARRANTY COUPON 1 for repair replacement within the warranty period Biofeedback trainer Mitsar BFB serial manufacturing date date signature and the seller s seal Commissioned date signature and the seller s seal Assigned for warranty service by Head of the enterprise signature and stamp The customer s signature Mitsar BFB Operation Manual 20 MITSAR CO LTD WARRANTY COUPON 2 for repair replacement within the warranty period Biofeedback trainer Mitsar BFB serial manufacturing date date signature and the seller s seal
20. city The Amplifier Box is placed right against the wall under which electric lines or cables are run 7 The Amplifier Box is placed too close to a wide metal surface metal closet box safe etc or to a wall behind which such object is placed There is radio or TV transmitter radar station or There is a cable line with defective or ungrounded screen TV computer network etc in the wall Mitsar BFB Operation Manual 15 There is a sparkling electric switch defective fluorescent lamp s or such lamp s with a defective starter 10 There is a working engine source closely outside the building 1 Domestic electric appliances microwave oven coffee grinder etc are on at the time of examination 12 Cellular or radio telephone is used at the time of exploration The permanent disturbance means a disturbance noise which is always present at an EEG record The temporary disturbance means a disturbance noise which appears at the record from time to time It is recommended to start search for unsatisfactory record quality reason from electrode applying quality and operating condition and from grounding connection and its quality 4 Power cells The Amplifiers is energized from four batteries or accumulators type AA R6 Non hermetic batteries should not be used for power supply of the Amplifiers It is recommended to use alkaline cells or Ni MH accumulators from well known manufacturers 3 5
21. clearly worn distorted or contaminated should be replaced immediately with clean genuine replacement parts that have been manufactured by or available from Mitsar The responsibility of Mitsar for a non functioning product is limited by the warranty set forth in this guide Should repair or replacement of this product become necessary after the expiration of the warranty the customer should seek advice from Mitsar prior to such repair or replacement If this product is in need of repair it should not be used until all repairs have been made and the unit is functioning properly and is ready for use The owner of this product has the sole responsibility for any malfunction resulting from improper use or maintenance or repair done by anyone other than a qualified Mitsar representative and from any malfunction caused by any parts that have been damaged or modified by anyone other than a qualified Mitsar representative The owner of this product has the sole responsibility for connection devices to the system not corresponded to the electrical safety requirements class type BF standards IEC 60601 1 1988 IEC 60601 1 1 1992 IEC 60601 1 2 1993 IEC 60601 1 4 1996 CISPR 14 1 Ed 3 0 Add 1 2 1993 1998 for medical devices Mitsar BFB Operation Manual V Mitsar Warranty and Post Guarantee Obligations 1 9 The manufacturer guarantees compliance of the system with technical specifications subject to the customer s fulfillment of opera
22. d Please choose your search and installation options S Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed Search removable media floppy CD ROM Include this location in the search JEAUSBDRY Browse Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware 7 Click the Next button Windows will automatically install driver Mitsar BFB Operation Manual 22 Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for Mitsar Neurofeedback Device Click Finish to close the wizard E Cancel 8 Click the Finish button to complete installation 5 2 Jammer driver installation Jammer driver installation is executed in the same way CAUTION Before the Jammer connecting and its drivers installing it is necessary to complete Amplifier Box connecting and its drivers installing Mitsar BFB Operation Manual 23 6 Brain Tuner software installation To install BrainTuner program 1 Insert the CD to the corresponding drive 2 Open folder with name BrainTuner BrainTunerE 3 Run SETUP EXE program 4 Follow the instruction on t
23. er which provides coordination of microcontroller and USB serial data link Jammer delivery is implemented by DC Voltage 5V through the USB interface 3 3 Starting up 1 First engaging and testing of the equipment should be carried out by the manufacturer s representative s or by personnel specially trained by the manufacturer 2 The Biofeedback Trainer system does not require a special screened camera subject to absence of closely situated interference source radio or TV transmitter power transformer radar station X ray unit physiotherapy equipment etc 3 Place the Biofeedback Trainer s components at the site in accordance to safety measures described herein 4 Open the battery compartment and insert batteries into the cartridge Strictly observe the batteries polarity Now the unit is ready for operation 5 Place the Amplifiers Box on the table next to the examinee or on another appropriate surface It is not recommended to place the Amplifiers close to concrete or metal structures or close to power lines that may cause additional 50 60 Hz stray pick up 6 Connecting the Amplifier Box to the computer The Amplifier Box is connected to the computer via serial port type USB In order to connect them insert one connector of the cable into the PC s port and the other plug into the appropriate Amplifier Box connector The connector at the Amplifier Box s case is not used for another purpose Direct the cable s connector pr
24. he screen Welcome to the BrainTuner Setup program This program will install BrainTuner on your computer It is strongly recommended that you exit all Windows programs before running this Setup program Click Cancel to quit Setup and then close any programs you have running Click Next to continue with the Setup program WARNING This program is protected by copyright law and international treaties Unauthorized reproduction or distribution of this program or any portion of it may result in severe civil and criminal penalties and will be prosecuted to the maximum extent possible under law Cancel Press Next button to continue installation Choose Destination Location Ed Setup will install BrainT uner in the following folder To install to this folder click Next To install to a different folder click Browse and select another folder You can choose not to install BrainTuner by clicking Cancel to exit Setup Destination Folder C Mitsar BrainT uner Browse Mitsar BFB Operation Manual 24 Press Browse button if you would like to change location BrainTuner program Press Next button to continue installation Click the type of Setup you prefer then click Next Typical Program will be installed with the most common options Recommended for most users C Compact Program will be installed with minimum required options You may choose the options you want to install
25. his manual below see Chapter 4 Connect system to power source The power supply requirement is present at next table Power supply voltage 100 240 B Power supply frequency 50 60 Hz Power consumption not including the computers Turn on the system Install the system specific drivers and software and test the Biofeedback Trainer in correspondents to instructions presented in this manual below see Chapter 5 and 6 connected to power source A WARNING Do not open Biofeedback Trainer cases if the system is which should be maintained by user except the batteries inside Amplifier Box lt gt CAUTION There are no parts inside the Biofeedback Trainer components 2 6 Switching On and peripheral devices WARNING Turn off the system before connection additional components Mitsar BFB Operation Manual 4 gt CAUTION Switch on the system before connection the electrodes to patient To switch on the system press Power button on PC 2 7 Switching Off CAUTION Disconnect the electrodes from the patient before switching off the system Switch off the system before disconnecting it from power supply 2 8 Leakage current The Biofeedback Trainer conjointly with a line supplied PC complies with the electrical safety requirements class 1 type BF standards IEC 60601 1 1988 1994 IEC 60601 1 1 1992 IEC 60601 1 2 1993 IEC 60601 1 4 1996 CISPR 14 1
26. nt the wizard to do Install the software automatically Recommended Click Next to continue Bene 4 Select Install from a list or specific location Advanced and then click the Next button Found New Hardware Wizard Please choose your search and installation options St Search for the best driver in these locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed Search removable media floppy CD ROM Include this location in the search Browse Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware 5 Select Search the best driver in these locations uncheck Search removable media floppy CD ROM check Include this location in the search and then click the Browse button Mitsar BFB Operation Manual 21 Browse For Folder 2 xl Select the folder that contains drivers For your hardware ic BrainTuner 3 EEG2000 Psytask c NS WinEEG WinReo 1 EH H F To view any subfolders click plus sign above 2 6 Find USBDRV folder on your installation CD and then click the OK button Found New Hardware Wizar
27. of a type not recommended by the manufacturer e f batteries of not recommended type and or voltage were used e nacase of attempts of unauthorized repair or changes in internal connections e illegal copies of Mitsar software were used The present warranty does not include replacement of electrode sockets and battery cartridge and replacement of batteries Such defects may be eliminated at the customer s request against separate charge 10 The present warranty does not concern equipment not included into the delivery set see section 3 1 hereinabove if not stipulated otherwise by the delivery contract 11 Guarantee coupons are enclosed Mitsar BFB Operation Manual vi Safety Summary Read and follow all WARNINGS CAUTIONS and NOTES provided in this guide To avoid the possibility of injury damage to your system or data loss always observe these safety precautions during system operation WARNINGS WARNING Only trained personnel familiar with safety regulations is allowed to operate the Biofeedback Trainer WARNING Only personnel properly trained to operate the Biofeedback Trainer should use it for patient testing WARNING Do not make clinical decision base on Biofeedback Trainer measurement only Biofeedback Trainer is auxiliary device that give the additional information about patient state The diagnosis should be determined basing on totality of symptoms and measurements WARNI
28. on may cause loss of data in that recording If you experience frequent power interruptions Mitsar recommends the usage of an Uninterruptible Power Supply UPS to help prevent power interruptions CAUTION Mitsar amplifiers do not have build in protection from influence of defibrillator CAUTION Do not use Biofeedback Trainer in moist condition Otherwise you will increase the risk of electric shock the device may work incorrectly and you may damage the device CAUTION Do not spill any liquid on any part of Biofeedback Trainer including connectors batteries compartment cables and etc This will increase the risk of electricity shock and may damage the device 1 CAUTION There parts inside the Biofeedback Trainer components which should be maintained by user except the batteries inside Mitsar BFB Amplifier Box Never attempt to repair disassemble or reconstruct any unit A serious electric shock could result if you ignore this precautionary measure Mitsar BFB Operation Manual X gt CAUTION Do not autoclave any parts of Biofeedback Trainer lt gt CAUTION Do not use acetone for cleaning the components of system Equipment labeling The next symbols are used for Biofeedback Trainer parts labeling A This mark identifies TYPE BF APPLIED PART This mark identifies INTERNALLY POWERED EQUIPMENT This mark identifies manufactu
29. operly it should come into the socket without excessive force For correct choice of the PC s connector see the computer user s manual 7 Switch on the computer and install the Amplifier Box driver Methods of driver installation and use of the software are given in Chapter 6 of this manual Mitsar BFB Operation Manual 13 8 9 Connecting the Jammer to the computer The Jammer connected to the computer via serial port type USB In order to connect them insert one connector of the cable into the PC s port and the other plug into the appropriate Jammer connector The connector at the Jammer s case is not used for another purpose Direct the cable s connector properly it should come into the socket without excessive force For correct choice of the PC s connector see the computer user s manual WARNING The Mitsar BFB Jammer must not be situated closer than 1 5 m from a patient 10 Connecting the Jammer to the TV set and video player The Jammer connected to the TV set and video player via special cables Detailed instructions on connecting are contained in Chapter 4 The connector at the Jammer s case is not used for another purpose Direct the cable s connector properly it should come into the socket without excessive force For correct choice of the TV s and video player s connectors see theirs user s manual 11 Switch on the computer and install the Jammer driver Methods of
30. patient and the PC 5 The integrated insulating decoupling device in the Amplifier Box supports appropriate safety levels for the amplification module and for personal computer after interconnection 6 Electric strength of the isolation between the operating parts and the PC connection cable reinforced isolation withstands AC voltage of 4 kV at operating temperature 7 The connection cable has the length of 5 m at least for removing the PC from a patient s environment WARNING The personal computer as a part of Biofeedback Trainer must not be situated closer than 1 5 m from a patient Mitsar BFB Operation Manual 9 IEC 2513 2004 Figure 4 An example of patient environment Biofeedback Trainer must be connected to power supply line only via WARNING monitor printer set and video player as part of socket equipped with ground contact 8 Electric strength of the PC s insulation against power line must be not less than 1500 V 9 The Amplifier Box has the decoupling device providing electric strength not less than 4 kV AC for computer connection circuits 10 Only trained personnel familiar with safety regulations is allowed to operate the Biofeedback Trainer Mitsar BFB Operation Manual 10 3 2 Mitsar BFB Jammer The Mitsar BFB Jammer complies in accordance with the requirements of technical specifications TU 9441 005 521 18320 2005 The Jammer connector layo
31. re date Tr This mark identifies compliance with the Russian Federation safety standards GOST This mark identifies compliance with the Medical Device Directive MDD 93 42 EEC SN This mark identifies serial number Mitsar BFB Operation Manual xi 1 Biofeedback Trainer overview Biofeedback Psychophysiological Condition Trainer Mitsar BFB hereafter Biofeedback Trainer is intended for brain training by its potentials registering while the examinee is executing specially programmed actions and perceiving brain activity changes as visual and acoustic images Application area health centers hospitals medical research centers psychological correction offices at schools The trainer can be also used at home under the doctor s supervision The Biofeedback Trainer includes the bio signals converter hereinafter the Amplifier Box The Amplifier Box is controlled by means of the specially developed computer software The Biofeedback Trainer includes the video and audio signals converter hereinafter the Jammer The Amplifier Box is controlled by means of the specially developed computer software Biofeedback Trainer is not sterile Device does not directly contact the patients Accessories that contact patients such as electrodes and caps are the same as used with the legally marketed devices or are comprised of the same components materials as legally marketed accessories This document if intended for administrative
32. sfactory applying of signal electrodes additional indication for that is 50 60 Hz picked up in one or more channels e Unsatisfactory applying of neutral or reference electrodes additional indication for that is strong 50 60 Hz pickup in one or more channels e The electrodes wires or connectors are damaged e Powerful electric equipment presents in the neighborhood of the EEG room which generates strong noise X ray installations physiotherapy equipment etc e Computer grounding is poor or absent e The Amplifiers to computer connecting cable runs right against the computer s monitor e There are some individual properties of the patient s skin or his her mental state In this case it is necessary to apply the electrodes more thoroughly to set the patient at rest to ask him her to relax A list of reasons causing noises or disturbances during EEG taking is given hereunder Ne Reason Permanent Temporary disturbance disturbance 1 Computer is not grounded or it has a poor ground Yes Yes connection 2 The Amplifier Box is installed too close to computer s Yes monitor The Amplifier Box connecting cable runs right against Yes the computer s monitor There is powerful electric equipment in the neighborhood of the training room which generates strong noise X ray installations physiotherapy equipment etc cellular communication unit in the vicinity of the building the distance depends on the unit s capa
33. the data processes the data displays and prints out them stores the data to hard disk and provides user interface The software includes the next modules 1 BrainTuner software 2 Amplifier Box and Jammer device drivers for Windows 2 3 Electrodes Electrodes and electrodes caps are important component of Biofeedback Trainer but they are delivered separately All electrodes and electrodes positioning caps should be certified in compliance with domestic standards Mitsar Co Ltd recommends use the standard electrodes with touch proof connectors All electrodes used together with Biofeedback Trainer should be certified Mitsar Co Ltd does not provide the warranties of appropriate quality of EEG recording if not certified or damaged electrodes are used N WARNING The usage not certified electrodes can damage the system 2 4 Antivirus software The Biofeedback Trainer software can interfere with antivirus software This can result in data loss during EEG recording and BFB training The active scanning is not recommended gt CAUTION Do not use antivirus scanning during biofeedback training Mitsar BFB Operation Manual 3 2 5 System installation Before the beginning of installation read attentively this manual 1 Start with installation from checking the components and cables Be sure that these components have no damage Connect the components in accordance with connection diagrams presented in t
34. ting requirements described below Warranty period is 24 months beginning with the date of installation and commission date of signing of the commission deed If the BSC delivery set includes a computer and or other computer equipment video camera etc warranties for such equipment shall be stipulated separately Warranty for electrodes and electrode fixing devices is 12 months if not stipulated otherwise by the electrode manufacturer During warranty period the manufacturer will provide for the customer necessary consultation regarding operation of the system During warranty period the manufacturer undertakes against presentation of the filled guarantee coupon to restore serviceability of the system by means of setting up repair or replacement of the entire device or its parts The manufacturer shall inform the customer during warranty period on all new developments and modifications of the system and shall suggest substitution of earlier software versions for upgraded ones free of charge Post guarantee service for the system shall be carried out by the manufacturer under separate contract with the customer The warranty will be considered void e nacase of absence of guarantee coupon with date of commission manufacturer s signature and stamp e In a case of broken seals In a case of mechanical damages caused during operation e lf aliquid was poured over into the device including leakage of batteries
35. tuated closer than 1 5 m from a patient Mitsar BFB Operation Manual 19 5 Biofeedback Trainer drivers installation 5 1 Amplifier Box driver installation Corresponding driver should be installed for any device plugged in to USB input Driver installation is standard procedure performed by Windows XP To install driver user should perform a number of standard steps listed below 1 Insert the installation CD into your CD ROM DVD ROM 2 Connect your amplifiers USB cable to an available USB port on your computer Windows automatically detects the device Found New Hardware Wizard dialog box appears New Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking on your computer on the hardware installation or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software Yes this time only w and ever time connect device Click Next to continue lt Back Cancel 3 Select No not this time and then click the Next button Mitsar BFB Operation Manual 20 Found New Hardware Wizard Welcome to the Found New Hardware Wizard This wizard helps you install software for Mitsar Neurofeedback Device If your hardware came with an installation CD or floppy disk insert it now What do you wa
36. ut is presented on Figures 5 and 6 1 Figure 5 Mitsar BFB Jammer connectors and indicators layout front view 1 Audio Video input 2 Audio Video output 3 Power indicator green LED 4 4 USB connector Figure 6 Mitsar BFB Jammer connectors and indicators layout rear view 3 2 1 Jammer basic technical data Weight of the Jammer not more than 1 kg Weight of the package without a computer and a printer not more than 10 kg Dimensions of the Jammer 160 x 95 x 35 mm The Jammer operates by computer system The Jammer is provided from USB power supply supply voltage 5 0 V The Jammer consumption current not more than 0 25 A Video channel technical data field frequency 50 Hz line length 64 us television system PAL SEKAM 7 Electrical safety of the Jammer complies with the requirements for instruments with Mitsar BFB Operation Manual 11 internal power supply type BF standards IEC 60601 1 1988 8 The Biofeedback Trainer complete with line powered PC complies with the electrical safety requirements class 1 type BF standards 60601 1 1988 and IEC 60601 1 1 1992 9 Electromagnetic compatibility of the Biofeedback Trainer complies with requirements of standard IEC 60601 1 2 1993 10 Working condition temperature range 10 to 435 C moisture range 25 to 95 without condensation 3 2 2 Jammer simplified functional diagram
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